RecruitingNot ApplicableNCT05577845

5-HT3 Receptor Antagonist (Ramosetron) vs Loperamide for the Treatment of Low Anterior Resection Syndrome(RALARS)

Safety & Efficacy of 5-HT3 Receptor Antagonist (Ramosetron) Versus Loperamide for the Treatment of Low Anterior Resection Syndrome (RALLARS): Multicenter Randomized Controlled Trial


Sponsor

Seoul National University Hospital

Enrollment

212 participants

Start Date

Mar 27, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Safety \& Efficacy of 5-HT3 Receptor Antagonist (Ramosetron) versus Loperamide for the Treatment of Low Anterior Resection Syndrome (RALLARS): Multicenter Randomized Controlled Trial


Eligibility

Min Age: 19 Years

Inclusion Criteria5

  • mid and low rectal cancer (AV<15cm)
  • stage II, III, preop long-course CCRT, then ileostomy repair
  • about 1~12 months after operation (no stomy)
  • about 1~6 months after ileostomy repair
  • major LARS

Exclusion Criteria4

  • recurred rectal cancer
  • stage IV
  • IBD
  • uncontrolled preoperative fecal incontinence or constipation

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Interventions

DRUGRamosetron

Ramosetron, 4 weeks


Locations(1)

Seoul National University Hospital

Seoul, Jongro-gu, South Korea

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NCT05577845


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